PMA P830063S009
- Device
- PRISMAFLEX TPE 2000 WITH PLASMAFILTER PF2000N
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S009
- Product code
- MDP
- Decision date
- 2016-12-22
- Classification
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Approval order statement
- Change to the equipment used to extract oils from the fiber bundles.
Current openFDA PMA Record#
- Device
- PRISMAFLEX TPE 2000 WITH PLASMAFILTER PF2000N
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S009
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2016-12-22
- Decision code
- OK30
- Date received
- 2016-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the equipment used to extract oils from the fiber bundles.